Search by Drug Name or NDC

    NDC 67939-0020-10 Sodium Fluoride F 18 200 mCi/mL Details

    Sodium Fluoride F 18 200 mCi/mL

    Sodium Fluoride F 18 is a INTRAVENOUS INJECTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by The University of Utah DBA Cyclotron Radiochemistry Lab Huntsman Cancer Institute. The primary component is SODIUM FLUORIDE F-18.

    Product Information

    NDC 67939-0020
    Product ID 67939-020_d951aa31-f016-e2da-e053-2995a90a5b2d
    Associated GPIs
    GCN Sequence Number n/a
    GCN Sequence Number Description n/a
    HIC3 n/a
    HIC3 Description n/a
    GCN n/a
    HICL Sequence Number n/a
    HICL Sequence Number Description n/a
    Brand/Generic n/a
    Proprietary Name Sodium Fluoride F 18
    Proprietary Name Suffix n/a
    Non-Proprietary Name Sodium Fluoride F 18
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form INJECTION
    Route INTRAVENOUS
    Active Ingredient Strength 200
    Active Ingredient Units mCi/mL
    Substance Name SODIUM FLUORIDE F-18
    Labeler Name The University of Utah DBA Cyclotron Radiochemistry Lab Huntsman Cancer Institute
    Pharmaceutical Class Radioactive Diagnostic Agent [EPC], Radiopharmaceutical Activity [MoA]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA204497
    Listing Certified Through 2024-12-31

    Package

    NDC 67939-0020-10 (67939002010)

    NDC Package Code 67939-020-10
    Billing NDC 67939002010
    Package 10 mL in 1 VIAL, MULTI-DOSE (67939-020-10)
    Marketing Start Date 2012-07-11
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL 2144e4e4-4be5-4fc6-b966-bd525ac7e430 Details

    Revised: 3/2022